A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to gain information on whether apixaban, when administered to patients with advanced or metastatic cancer will be well-tolerated and acceptable as anticoagulant therapy. These patients are at increased risk for venous thromboembolic events (VTE). Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
ConditionThrombosis
Cancer
Pulmonary Embolism
InterventionDrug: Apixaban
Drug: Placebo
PhasePhase 2
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00320255
First ReceivedApril 28, 2006
Last UpdatedFebruary 28, 2012
Last verifiedFebruary 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 28, 2006
Last Updated DateFebruary 28, 2012
Start DateJune 2006
Estimated Primary Completion DateJanuary 2009
Current Primary Outcome MeasuresThe occurrence of either a major bleeding (fatal or non-fatal) event or a clinically relevant non-major bleeding event [Time Frame: during the treatment period] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresSymptoms compatible with venous thromboembolism [Time Frame: during the treatment and 30 day follow-up periods] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Official TitleA Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study
Brief Summary
The purpose of this study is to gain information on whether apixaban, when administered to
patients with advanced or metastatic cancer will be well-tolerated and acceptable as
anticoagulant therapy. These patients are at increased risk for venous thromboembolic
events (VTE). Demonstration of a favorable benefit:risk profile could lead to significant
reduction in this serious and sometimes fatal complication of ongoing cancer and its
treatment.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Condition
  • Thrombosis
  • Cancer
  • Pulmonary Embolism
InterventionDrug: Apixaban
Tablets, Oral, 5 mg QD, once daily for 12 weeks
Other Names:
BMS-562247Drug: Placebo
Tablets, Oral, 0 mg, once daily for 12 weeks
Study Arm (s)
  • Active Comparator: A1
  • Placebo Comparator: A2

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment129
Estimated Completion DateJanuary 2009
Estimated Primary Completion DateJanuary 2009
Eligibility Criteria
Inclusion Criteria:

- Advanced or metastatic cancer

- Chemotherapy for ≥90 days

- Enter study within 6 wks start of chemo

Exclusion Criteria:

- Women who are pregnant, breastfeeding

- Venous Thromboembolic Events (VTE) history

- Active/high risk of bleeding

- Metastatic brain cancer

- Expected survival < 6 months

- Bone marrow transplant candidate

- Low platelet count

- ALT >3xULN, bilirubin > 2xULN, Clcr <30 mL/min

- Receiving Plavix® Aggrenox™

- Receiving bevacizumab (Avastin™ ) for off-label/investigational indications

- Receiving Nexavar® or Sutent® (within 3 months)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada

Administrative Information[ + expand ][ + ]

NCT Number NCT00320255
Other Study ID NumbersCV185-027
Has Data Monitoring CommitteeYes
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsOntario Clinical Oncology Group (OCOG)
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateFebruary 2012

Locations[ + expand ][ + ]

Arizona Cancer Center
Tucson, Arizona, United States, 85724
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02115
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Mount Sinai School Of Medicine
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
University Of Rochester
Rochester, New York, United States, 14642
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030
Local Institution
Hamilton, Ontario, Canada, L8V 2C5
Local Institution
London, Ontario, Canada, N6A 4L6
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Local Institution
Toronto, Ontario, Canada, M4N 3M5
Local Institution
Montreal, Quebec, Canada, H3G 1A4
Local Institution
Montreal, Quebec, Canada, H1T 2M4